CLASS II Device recall · Reported 15 Nov 2017 · FDA Enforcement Report
Ams, Aligned Medical Solutions, T&a Pack, AMS6357, Sterile EO recalled
Windstone Medical Packaging is recalling Ams, Aligned Medical Solutions, T&a Pack, AMS6357, Sterile EO, distributed in South Carolina. The recall was initiated on 24 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0069-2018
- FDA event ID
- 78366
- Recalling firm
- Windstone Medical Packaging, Billings, MT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2017
- FDA classified
- 7 Nov 2017
- Reported
- 15 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 24 Oct 2017 | Recall initiated by company | |
| 7 Nov 2017 | Classified by FDA | +14 days |
| 15 Nov 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Where it was distributed
US Distribution to the state of : SC
Questions about this recall
Is Ams, Aligned Medical Solutions, T&a Pack, AMS6357, Sterile EO recalled?
Yes. Windstone Medical Packaging recalled Ams, Aligned Medical Solutions, T&a Pack, AMS6357, Sterile EO on 24 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0069-2018.
Why was it recalled?
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Which lots are affected?
Lot # 109138
Where was it sold?
US Distribution to the state of : SC
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Windstone Medical Packaging
All 337| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |